BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUGE

    MDR report key: 2163634 · Received July 11, 2011

    Report

    Report Number
    MW5021332
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 0.014 GRAPHIX GUIDEWIRE WAS PASSED THROUGH THE STENT STRUTS IN THE LAD ALONGSIDE THE 0.014 LUGE GUIDEWIRE WHICH HAD BEEN LEFT IN THE DIAGONAL BRANCH TO PROTECT THE OSTIUM DURING DEPLOYMENT OF THE STENT. UPON PULLING BACK THE LUGE GUIDEWIRE THE DISTAL TIP SEPARATED AND REMAINED IN THE VERY DISTAL DIAGONAL BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE LUGE WIRE GUIDEWIRE WITH ICE HYDROPHILIC COATING DQX BOSTON SCIENTIFIC 13748085

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR